Accurate Recognition of Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Airway Obstruction Clinical Trial

Official title:

Generation and Cognitive Testing of Informative and Suitable Items for a COPD Exacerbation Recognition Tool (CERT) for Detection of Exacerbations of COPD in Chinese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170999
• Other study ID #: 201098
• Status: Completed
• Start date: January 29, 2018
• Est. completion date: May 29, 2020

Study information

• Verified date: July 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It has been observed that COPD exacerbations are under-reported in China. One of the reasons for this is Chinese subjects with COPD cannot describe the symptoms of exacerbation mentioned in English. Hence this study aims to create a tool called CERT that will help Chinese physicians and subjects with COPD to recognize and report exacerbations. The study will be carried out in 4 stages: item identification, cognitive briefing, item reduction and creation of final CERTs. Two CERTs will be prepared, one for subjects with COPD and another for physicians. A total of approximately 200 subjects will be included in the study and each subject will contribute to only one step.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: May 29, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Male or female of age greater than or equal to 40 years.

• Spirometrically confirmed COPD according to diagnostic criteria in Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016.

• A treated exacerbation of COPD within 3 months prior to the study visit.

• Willing and able to provide informed consent, and able to participate in focus groups or cognitive interviews.

• Literacy is not a requirement for any of the groups.

Exclusion Criteria:

• Current diagnosis of asthma or clinically relevant bronchiectasis. Note: Subjects with Asthma COPD Overlap Syndrome (ACOS) are eligible.

• Subjects with a concurrent significant, uncontrolled, active medical condition or disease state of other organ diseases or systematic diseases; psychiatric condition; cognitive impairment or any other reasons that in the investigator's opinion, would place subjects at risk or interfere with study evaluation or affect participation in the study.

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

Other:
• Focus group interview
Focus group interviews will take place to discuss the key domains of COPD exacerbation which then will be used in the formation of the draft item set.
• Draft item set
Items that form the draft item set will be subject to cognitive debriefing. Questions in the draft item set will collect information on whether the subjects with COPD have experienced that item during an exacerbation. Changes in this draft set will result in the formation of candidate item set.
• Candidate item set
Item reduction will be done using candidate item set and the subjects will be asked to respond to the candidate items on a 4-point scale in terms of how that item changed with the onset of the last episode. Item reduction will take into account frequency and magnitude of items, floor and ceiling items and consistency between regions. The candidate item set will then be used for generation of CERT.

Locations

Country	Name	City	State
China	GSK Investigational Site	Chongqing
China	GSK Investigational Site	Hangzhou	Zhejiang
China	GSK Investigational Site	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COPD symptom item set to identify common phrases of COPD exacerbation	The most frequently used items to describe the symptomatic characteristics of the onset of an exacerbation will be identified from COPD symptom item set.	Day 1
Primary	Preparation of COPD Exacerbation Recognition tool (CERT)	Two simple educational hand-outs called CERT will be prepared, one for the subjects with COPD and the other for the physicians which will help Chinese physicians and subjects in recognizing and reporting COPD exacerbations.	Day 1